MultimorbidityNCT03589716
Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform
A study testing Vital Moto Mod, Welch Allyn Connex Spot Vital Signs Monitor and Capnostream 20 Portable Bedside Capnograph in people with Multimorbidity, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multimorbidity
- What is being tested?
- Vital Moto Mod, Welch Allyn Connex Spot Vital Signs Monitor and Capnostream 20 Portable Bedside Capnograph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 265 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For volunteers with one or more vital signs presumed to be within normal physiological range, at rest:
- Age ≥ 18 years
- Willing to allow arm and finger size to be measured
- Willing to allow measurement of skin color (optional)a
- Willing to undergo exercise testing (optional);
- Willing to allow an arterial blood gas draw (optional);
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- For volunteers with one or more vital signs expected to be outside of normal physiological range, at rest:
- Age≥18 years
- Willing to allow arm and finger size to be measured
- Willing to allow measurement of skin color (optional)
Who cannot join
- For Volunteers Undergoing Heart Rate and Oxygen Saturation Measurement:
- Nail paint or artificial nail on the index finger of the left hand
- SpO2 less than 94%
- For Volunteers Undergoing Exercise Testing with Vital Signs within Normal Physiological Range, at rest:
- Volunteers with vital signs outside of normal physiological range (ascertained during measurements conducted at study site before exercise testing)
- Age 65 years or older
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- Consumption of food, alcohol or caffeine (coffee, tea or caffeinated soft-drinks) in a 3-hour period prior to testing
- Uncomfortable clothing, or inappropriate footwear for exercise testing
- Self-report of any of the following:
- History of fall or fracture in the past year
- History of arthritis
- History of dizziness
- History of neurological illness
- History of chest pain or myocardial infarction
- History of hypertension or diabetes mellitus
- History of heart disease
- History of stroke or transient ischemic attack
- Active treatment for anemia, electrolyte imbalance, or hyperthyroidism
- Physical disability that precludes safe and adequate testing
- Mental impairment with limited ability to cooperate4
- Pregnancy (Volunteer will be excluded if either of the following is true: a) self-report of being pregnant; b) positive urine pregnancy test)
- For Volunteers undergoing an Arterial Blood Gas Draw with Vital Signs within Normal Physiological Range, at rest:
- Self-reported history of a clotting disorder of the blood, or active treatment with medicines affecting blood clotting (e.g. Warfarin).
Trial locations and contacts
1 site in 1 country.
United States1 site
Partners Connected Health
Boston, Massachusetts, 02114
About this study
Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.
Read the detailed description
To assess the comparative clinical performance of the Vital Moto Mod device in the measurement of five vital signs (body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure) in correlation with a reference device used in the hospital environment for vital sign measurement.
Vital sign measurement is a core process in delivering healthcare. Body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure are some of the most frequently measured vital signs in inpatient as well as outpatient encounters. Currently, separate devices exist for measurement of each of these vital signs, each of which may have to be measured several times in a day. Consequently, measurement of vital signs is a time and human resource intensive process. Moreover, most of the devices currently used to measure vital signs cannot transmit data to the electronic medical record of patient, thereby creating opportunities for human error. VVVital USA has used proprietary sensor technology to develop Vital Moto Mod - a vital sign measurement platform that can non-invasively measure body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure from a person's index finger, and allows this information to be pushed into their electronic medical/health record from the point of care
The primary market focus use of the Vital Moto Mod is to replace the vital sign cart in hospitals. Vital sign carts are expensive and cumbersome to move around the hospital. At a fraction of the cost, the Vital Moto Mod provides the same functionality including bar code scanning at a fraction of the cost. Additionally, the Vital Moto Mod can also be used at home without the need for a trained nurse. The Vital Moto Mod App will guide a user through the workflow of performing the measurements. The Vital Moto Mod is connected to a smartphone for storage, and has a USB interface for charging, thereby requiring no electrical connections during use. All measurements are taken by the device independent of the phone.
Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.
- Conditions
- Multimorbidity
- Being tested
- Vital Moto Mod, Welch Allyn Connex Spot Vital Signs Monitor, Capnostream 20 Portable Bedside Capnograph, Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope, Scifit 1000R cycle ergometer
- Keywords
- Vital Signs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital Moto ModOther
All participants receive vital signs measurement using the Vital Moto Mod device and reference devices. The vital signs measured are blood pressure, heart rate, respiratory rate, oxygen saturation and temperature.
Welch Allyn Connex Spot Vital Signs MonitorOther
This is the FDA approved reference device to measure heart rate, SpO2 and temperature.
Capnostream 20 Portable Bedside CapnographOther
This is the reference device to be used to obtain etCO2 waveforms for respiratory rate assessment.
Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching StethoscopeOther
These reference devices will be used together for blood pressure measurements.
Scifit 1000R cycle ergometerOther
This is the device that will be used for exercise testing
| Study group | Role | What they receive |
|---|---|---|
| Participants with Vital Signs Within Normal Range | Other | All participants will be asked to have an arm and finger measurement conducted and undergo vital sign measurements using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiration rate, blood oxygen saturation, and temperature. Participants with vital signs within the normal physiological range will also be asked to perform an optional exercise testing and/or undergo arterial blood gas measurement. Receives: Other: Vital Moto Mod; Other: Welch Allyn Connex Spot Vital Signs Monitor; Other: Capnostream 20 Portable Bedside Capnograph; Other: Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope; Other: Scifit 1000R cycle ergometer |
| Participants with Vital Signs Outside of Normal Range | Other | All participants will be asked to have an arm and finger measurement conducted and undergo vital sign measurements using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiration rate, blood oxygen saturation, and temperature. Participants with vital signs outside of the normal physiological range would be documented. Receives: Other: Vital Moto Mod; Other: Welch Allyn Connex Spot Vital Signs Monitor; Other: Capnostream 20 Portable Bedside Capnograph; Other: Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Vital Moto Mod vital signs measurements in agreement with reference device vital signs measurements
Vital signs measurements for each participant would be compared using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiratory rate, oxygen saturation and temperature
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start23 Jul 2018
- Primary completion8 Mar 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vital USA, Inc.
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Kamal Jethwani, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589716
- Sponsor's protocol ID
- 2018P000152
- Status last verified
- Aug 2020
- First submitted
- 4 Jun 2018
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Accuracy of an Integrated Vital Sign Measurement Platform
- ClinicalTrials.gov ID
- NCT03589716
- Acronym / sponsor ID
- 2018P000152
- Conditions
- Multimorbidity
- Keywords
- Vital Signs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Vital USA, Inc.
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.
Detailed description
To assess the comparative clinical performance of the Vital Moto Mod device in the measurement of five vital signs (body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure) in correlation with a reference device used in the hospital environment for vital sign measurement.
Vital sign measurement is a core process in delivering healthcare. Body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure are some of the most frequently measured vital signs in inpatient as well as outpatient encounters. Currently, separate devices exist for measurement of each of these vital signs, each of which may have to be measured several times in a day. Consequently, measurement of vital signs is a time and human resource intensive process. Moreover, most of the devices currently used to measure vital signs cannot transmit data to the electronic medical record of patient, thereby creating opportunities for human error. VVVital USA has used proprietary sensor technology to develop Vital Moto Mod - a vital sign measurement platform that can non-invasively measure body temperature, respiratory rate, heart rate, oxygen saturation and blood pressure from a person's index finger, and allows this information to be pushed into their electronic medical/health record from the point of care
The primary market focus use of the Vital Moto Mod is to replace the vital sign cart in hospitals. Vital sign carts are expensive and cumbersome to move around the hospital. At a fraction of the cost, the Vital Moto Mod provides the same functionality including bar code scanning at a fraction of the cost. Additionally, the Vital Moto Mod can also be used at home without the need for a trained nurse. The Vital Moto Mod App will guide a user through the workflow of performing the measurements. The Vital Moto Mod is connected to a smartphone for storage, and has a USB interface for charging, thereby requiring no electrical connections during use. All measurements are taken by the device independent of the phone.
Partners Connected Health will conduct a clinical validation study to evaluate the accuracy of measurement for each vital sign with the Vital Moto Mod platform, compared to appropriate reference devices used in the hospital setting. The study will recruit volunteers from the Partners Healthcare network of clinics and hospitals and the general public.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Vital Signs Within Normal Range | Other | Other: Vital Moto Mod, Other: Welch Allyn Connex Spot Vital Signs Monitor, Other: Capnostream 20 Portable Bedside Capnograph, Other: Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope, Other: Scifit 1000R cycle ergometerAll participants will be asked to have an arm and finger measurement conducted and undergo vital sign measurements using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiration rate, blood oxygen saturation, and temperature. Participants with vital signs within the normal physiological range will also be asked to perform an optional exercise testing and/or undergo arterial blood gas measurement. |
| Participants with Vital Signs Outside of Normal Range | Other | Other: Vital Moto Mod, Other: Welch Allyn Connex Spot Vital Signs Monitor, Other: Capnostream 20 Portable Bedside Capnograph, Other: Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching StethoscopeAll participants will be asked to have an arm and finger measurement conducted and undergo vital sign measurements using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiration rate, blood oxygen saturation, and temperature. Participants with vital signs outside of the normal physiological range would be documented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- For volunteers with one or more vital signs presumed to be within normal physiological range, at rest:
- Age ≥ 18 years
- Willing to allow arm and finger size to be measured
- Willing to allow measurement of skin color (optional)a
- Willing to undergo exercise testing (optional);
Key exclusion criteria (23 listed)
- Nail paint or artificial nail on the index finger of the left hand
- SpO2 less than 94%
- For Volunteers Undergoing Exercise Testing with Vital Signs within Normal Physiological Range, at rest:
- Volunteers with vital signs outside of normal physiological range (ascertained during measurements conducted at study site before exercise testing)
- Age 65 years or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vital Moto ModAll participants receive vital signs measurement using the Vital Moto Mod device and reference devices. The vital signs measured are blood pressure, heart rate, respiratory rate, oxygen saturation and temperature. | Other | Participants with Vital Signs Outside of Normal Range, Participants with Vital Signs Within Normal Range |
| Welch Allyn Connex Spot Vital Signs MonitorThis is the FDA approved reference device to measure heart rate, SpO2 and temperature. | Other | Participants with Vital Signs Outside of Normal Range, Participants with Vital Signs Within Normal Range |
| Capnostream 20 Portable Bedside CapnographThis is the reference device to be used to obtain etCO2 waveforms for respiratory rate assessment. | Other | Participants with Vital Signs Outside of Normal Range, Participants with Vital Signs Within Normal Range |
| Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching StethoscopeThese reference devices will be used together for blood pressure measurements. | Other | Participants with Vital Signs Outside of Normal Range, Participants with Vital Signs Within Normal Range |
| Scifit 1000R cycle ergometerThis is the device that will be used for exercise testing | Other | Participants with Vital Signs Within Normal Range |
Primary outcome
Number of Vital Moto Mod vital signs measurements in agreement with reference device vital signs measurements
Time frame: 1 day
Vital signs measurements for each participant would be compared using the Vital Moto Mod and reference devices for blood pressure, heart rate, respiratory rate, oxygen saturation and temperature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Jethwani principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vital Moto Mod, Welch Allyn Connex Spot Vital Signs Monitor and Capnostream 20 Portable Bedside Capnograph in people with Multimorbidity, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Vital Moto Mod vital signs measurements in agreement with reference device vital signs measurements (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2020.